タルサス・ファーマシューティカルズ（TARS）2026年第3四半期決算説明会：XDEMVYの売上高ガイダンスを上方修正

主要要点

• 2026年第3四半期のXDEMVYの製品売上高（純額）は前年同期比約64%増の1億9,460万ドルと過去最高を記録し、売上総利益率は約93%となりました。
• Tarsusは、患者需要の拡大、処方の深化、ならびに消費者向け直接広告（DTC）の投資対効果向上を理由に、2026年通期のXDEMVY売上高見通しを7億1,500万ドル〜7億3,000万ドルに上方修正しました。
• 当四半期の処方の約20%は再治療の患者によるものでした。経営陣は、長期的な再治療率は20%台前半で推移すると予想しています。
• 発売以来、100万本以上のXDEMVYが処方され、累計製品売上高（純額）は10億ドルを超えました。経営陣は引き続き、年間売上高のピーク時に20億ドル以上を目指しています。
• Tarsusは当四半期末時点で約3億1,000万ドルの現金及び現金同等物を保有し、TPO-4、TPO-5、IRX-101、およびAlkeusのスターガルト病プログラムを進展させています。
• 経営陣は、TPO-4およびTPO-5の主要結果（トップラインデータ）の発表を2027年前半、スターガルト病を対象とした第III相NORTH STAR試験の結果発表を2029年後半と見込んでいます。

主要財務データ

事業および業績の動向

XDEMVYの成長は、新規患者需要、眼科医療従事者における処方の広がりと深化、そして再治療という3つの要因によって支えられました。

オンラインチャット、症状評価ツール、医師検索の利用などの高価値な患者のアクションは、当四半期中に75%増加しました。Tarsusは処方への転換率も前年同期より高かったと述べています。同社は通期のDTC予算を500万ドル増額し、約9,500万ドルとしました。

1週間あたり少なくとも5件のXDEMVY処方箋を発行する眼科医療従事者の数は、第2四半期から約20%増加しました。経営陣によると、医師たちがニキビダニ眼瞼炎のスクリーニング、治療、再治療を日常診療に取り入れる動きが加速しています。

第3四半期の処方のうち再治療が約20%を占めました。Tarsusはこの割合が20%台前半で安定し、治療経験のある患者基盤が拡大するにつれて継続的な需要源になると見込んでいます。

中国では、TarsusのパートナーがTPO-3を発売しました。同社は、最恵国待遇規制の影響を考慮し、欧州および日本でのTPO-3の規制当局への承認申請を延期しました。

業績予想（ガイダンス）

経営陣は、売上高予想の上方修正について、患者需要の拡大、複数の患者セグメントでの利用拡大、およびDTC広告の投資対効果の向上を反映したものであると説明しました。また、この見通しには第4四半期の医学会や休日も考慮されています。

2027年について、経営陣は43%〜45%の総売上高から純売上高への値引き率（Gross-to-Net割引）が引き続き適切な前提条件であると述べています。DTC支出については現在検討中ですが、投資額はおおむね2026年の水準を維持しつつ、より高いリターンが見込めるチャネルや時期に資金を配分する見込みです。

Tarsusは、IRX-101の第III相COMFORT試験が2027年前半に開始され、2028年に主要結果が得られると予想しています。承認までの推定開発費用は2,000万ドル〜3,000万ドルです。

スターガルト病を対象とした第III相NORTH STAR試験の患者登録は順調に進んでおり、主要結果は2029年後半に発表される予定です。経営陣は承認までの費用を1億5,000万ドル〜2億ドルと見積もっています。

リスクと注目点

• 経営陣はXDEMVYを非慢性疾患用治療薬と位置付けており、自動的な継続使用のみに依存するのではなく、常に新たな処方を創出し続ける必要があることを意味しています。
• 第4四半期の売上高は医学会や休日の影響を受ける可能性がありますが、これらは改定後のガイダンスに反映されています。
• 最恵国待遇規制の影響により、欧州および日本でのTPO-3の承認申請は延期されました。
• FDA（米国食品医薬品局）はNORTH STAR試験の設計と主要評価項目を承認していますが、TarsusはALK-001に関する追加の第III相試験が必要になるかどうかについて協議を継続しています。
• Alkeusの製品の物質特許は既に失効しています。Tarsusは現在、用途特許による保護の可能性を検討しつつ、承認から約7年〜7.5年間の希少疾病用医薬品（オーファンドラッグ）としての独占販売権を強調しています。
• TPO-4の想定される第III相試験の設計および費用は、進行中のお酒さ（眼酒さ）試験の結果およびその後の規制当局からのフィードバックに依然として依存しています。

アナリスト質疑応答の要点

XDEMVYの需要： 経営陣は成長の要因として、DTC広告、営業チームの実行力、臨床的エビデンス、および再治療の複合的な効果を挙げました。Tarsusによると、DTC施策を通じて現在患者の3人に1人がニキビダニ眼瞼炎を認知しており、同社が接触した調査対象の眼科医療従事者の98%がXDEMVYに満足していると回答しました。

再治療： 臨床医を対象とした調査によると、患者の約20%〜25%が再度治療コースを必要とする可能性があることが示されています。再治療は症状や臨床所見の再発によって引き起こされる可能性があり、マイボーム腺機能不全や眼酒さなどの疾患がそのリスクを高める可能性があります。

競合および知的財産： 経営陣は、競合製品は有効性と安全性において高いハードルに直面すると述べ、1日2回使用のクリーム剤よりも点眼剤の方が好ましい可能性があると主張しました。XDEMVYの知的財産保護期間は2038年まであり、ハッチ・ワックスマン法に基づく延長も適用される可能性があります。

IRX-101の保険償還および開発： Tarsusは、IRX-101がJコードを通じて個別支払を受け、発売時にはCコードが付与される可能性があると見込んでいます。本製品は診療所でのバイ・アンド・ビル（買い取り請求）モデルを想定しています。経営陣は本製品を眼科用殺菌・消毒薬としての適応を目指す新化学物質（NCE）であると説明しました。

眼酒さ： TPO-4試験では、眼周部紅斑や毛細血管拡張を含む炎症関連の評価項目を評価しています。結果が良好であれば、経営陣は2027年後半または2028年に第III相試験を開始できる可能性があると述べました。

スターガルト病： 経営陣は、ALK-001が正常な視覚サイクルをサポートするよう設計された1日1回投与の経口治療薬であると説明しました。FDAはNORTH STAR試験の設計と評価項目を承認していますが、同社は規制当局との協議が続く中、もう1つの第III相試験を実施する選択肢も保持しています。

決算説明会 文字起こし全文

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Hello, and welcome to Tarsus Pharmaceuticals Third Quarter 2026 Financial Results Conference Call. As a reminder, this call is being recorded. [Operator Instructions]

At this time, I would like to turn the call over to David Nakasone, Head of Investor Relations, to lead off the call. David, you may begin.

David Nakasone

Thank you. Before we begin, I encourage everyone to visit the Investors section of the Tarsus website to view the press release issued today and related materials we will be discussing today. Joining me on the call today are Bobby Azamian, Chief Executive Officer and Chairman; Neera Clase, our Chief Commercial Officer; Jeff Farrow, our Chief Financial Officer and Chief Strategy Officer; -- and joining us for Q&A is Dr. Liz Yeu, our Chief Medical Officer; and Sesha Neervannan, our Chief Operating Officer. I'd like to draw your attention to Slide 3, which contains our forward-looking statements. During this call, we will be making forward-looking statements that are based on our current expectations and beliefs.

These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors contained in our SEC filings for additional details.

With that, I will turn the call over to Bobby.

Bobak Azamian

Good afternoon, and thank you for joining us. [indiscernible] more than 1 million bottles of XDEMVY dispensed, more than $1 billion in cumulative net product sales in a pipeline with the potential to bring 5 new medicines to patients in the next 5 years. As we celebrate our tenth anniversary, those numbers stay a lot about how far Caris has come. But what excites me the most is what they tell us about where we can go. We started with a conviction that there were important diseases in eye care hiding in plain sight and that following the science to their root cause could lead to entirely new categories of medicine. XDEMVY showed what that conviction could accomplish. This quarter, we delivered record sales and are again raising our full year outlook.

Neera and Jeff will take you through the details and why we believe XDEMVY is just getting started. I want to talk about our broader ambition, building the next leader in eye care, not one defined by a single drug, but by a repeatable ability to spot a disease the field has overlooked bring forward a medicine that could change how it's treated and bring it to patients. That's the standard we're applying across our pipeline. We want to be first or best and we're choosing opportunities where we believe we can make a meaningful difference.

With Stargardt disease, that means the potential to help children and young adults preserve vision they would otherwise lose with iRenix 101, it means improving antiseptic preparation for patients receiving repeated retinal injections. And with our existing investigational programs for ocularization and Lyme disease prevention, we have opportunities to address other diseases where patients still need better answers. Together, they give us what we believe is one of the most differentiated pipelines in eye care. 3 years ago, we were launching a single product for a disease most people have never heard of. Today, we're a team that built the category from scratch, closed 2 acquisitions in 2 months and is running several clinical programs. There was no playbook for any of it, so we wrote one. And the people who wrote it have grown with every chapter.

Neera is a wonderful example. She joined us early in the Charcas journey and started where it matters most prioritizing patients can access and afford XDEMVY. That became the foundation for everything that follows. Since then, she has helped build the XDEMVY launch into one of the best in eyecare and I'm very proud to Haver as our Chief Commercial Officer. 1 million bottles shows what this team could do, $1 billion shows the model works, 5 and 5 is what we plan for next.

Neera, over to you.

Neera Clase

Thank you, Bobby. I'm honored to lead our commercial organization at such an important time for Tarsus. I know this business and this team well and I've never been more confident in the opportunity ahead for XDEMVY. XDEMVY delivered another record quarter in Q3, approximately $195 million in net product sales up nearly 64% year-over-year. And we did it in a seasonally softer quarter when vacations and medical meetings mean fewer days in the office. Even so, weekly prescriptions of XDEMVY reached an all-time high, and that momentum has continued into the fourth quarter.

There are 3 reinforcing pillars driving growth. one, increasing demand as more patients recognize their symptoms and ask about XDEMVY; two, broader and deeper prescribing among our target eye care professionals or ECP and three, a growing contribution from retreatments due to positive experiences from patients and their ECP. The ongoing progress we are seeing on all 3 fronts reinforces our belief that we're still in the early phases of XDEMVY's growth trajectory. Let's begin with the new patient demand. The synergy between our branded advertising, John's CNA campaign and unbranded disease education efforts are helping more people recognize their symptoms and take action. What matters most isn't how many people see the campaign. It's what they do next.

Patients are using our chat, taking the you might be right with and searching for a doctor. All signals that they intend to seek care, those high-value actions grew 75% this quarter, and we're converting prescriptions at a higher rate than last year. That's why we're adding $5 million to our DTC spend, bringing our full year investment to approximately $95 million, and we'll focus those dollars on the channels producing the strongest results. The second driver is ECP utilization where prescribing is both deepening and broadening. In the third quarter, the number of ECPs writing at least 5 prescriptions per week who we call daily prescribers grew approximately 20% over the second quarter. That matters because it shows that screening and treatment for Demodex blepharitis or DB have become a routine part of their practices. Additionally, our growing body of real-world evidence is giving those ECPs more reasons to screen. At the recent American Academy of Optometry or AAO meeting, we presented a chart review that identified DB in 91% of patients with recurrent Celecia, or Horda. Finding Slide 6 show ECPs where DB may be hiding in their practices and underscores their belief in the number of patients that could benefit from XDEMVY.

The third driver is retreatment. This quarter, approximately 20% of prescriptions were for patients returning for another course of therapy, and we believe it will settle in the low 20% range over time. On a growing base of treated patients, that can become an increasingly meaningful and durable source of demand. Put together, new patient demand broader and deeper ECP adoption and retreatment show how durable the XDEMVY opportunity is. Approximately 25 million Americans are affected by DB -- even with more than 1 million bottles dispensed to date, we've reached only a fraction of the potential market. We're still building the category expanding the disease recognition and helping ECPs make DB screening a routine part of eye care. That progress reinforces our confidence in XDEMVY's potential to exceed $2 billion plus in peak annual sales and supports the increased full year outlook Jeff will discuss next.

To our commercial team, thank you for your disciplined urgency and patient focus behind these results. You've built tremendous momentum and we're energized for the opportunity ahead in 2027.

Jeff, over to you for the financial results, updated guidance and pipeline progress.

Jeffrey S. Farrow

Thanks, Neera. XDEMVY's continued growth is giving us greater opportunities to invest in Tarsus' future. Our job is to put that capital to work where it can create the greatest value. expanding extends reach and advancing our pipeline through its next clinical milestones. We are making those decisions with discipline, directing commercial investments toward the opportunities generating the strongest returns and planning development spending around advancing each of our programs. Starting with our third quarter results. We delivered XDEMVY net product sales of $194.6 million driven by strong prescription volumes. Gross margin of approximately 93%, and we ended the quarter with cash and cash equivalents of approximately $310 million.

Turning to expenses. SG&A expense was $168 million. Excluding cost of the Alkeus acquisition, the year-over-year increase was primarily due to DTC and other promotional investments, our new key account leader team and higher variable costs as XDEMVY volumes grew. R&D expense was $44 million for the quarter, excluding costs of the Altice acquisition. The year-over-year increase was primarily due to TPO 4, TPO and IRX 101 and other ongoing programs. Acquired in-process research and development, or IP R&D charges totaled $632 million comprising $81 million for ironic and $551 million for Alkeus. Additional details on the accounting for both transactions are available in our Form 10-Q issued earlier today.

Now turning to our updated full year 2026 guidance. We expect our full year 2026 XDEMVY sales outlook to be between $715 million to $730 million. The updated range reflects increased trends we are seeing in patient demand, deeper ECP utilization across multiple patient segments and stronger returns from our DTC investment. It also accounted for the usual medical meetings and holidays that occur in the fourth quarter. Gross margin to remain steady at approximately 93%. SG&A expense of $605 million to $620 million which includes stock compensation of $45 million to $50 million. This anticipated increase is due to higher variable fees driven by growing XDEMVY volumes, increased DTC investments bringing our full year spend to approximately $95 million and integration costs related to Alkeus.

In R&D expense of $140 million to $155 million which includes stock compensation of $20 million to $25 million, reflecting progress across our clinical programs and the integration of the Alkeus and iRenix programs. Turning to our pipeline and international plans. In China, our partner launched TPO 3. Similar to other companies, we have made the decision to defer regulatory filings for TPO 3 in Europe, in Japan, in light of the current implications of most favored nation regulations. For TPO 4 in ocular rosacea and TPO 5 in line disease prevention, both investigational programs remain on track with top line results expected in the first half of 2027. For IRX 101, our investigational ocular an aseptic, we anticipate initiating the Phase III COMFORT study in the first half of 2027 with top line results expected in 2028. We currently estimate the cost to approval to be in the range of $20 million to $30 million. For our investigational medicine, kidoretinol and Stargardt disease, Enrollment continues to progress in the Phase III NORTH STAR study with top line results expected in the second half of 2029. We currently estimate the cost to approval at $150 million to $200 million.

To sum up, XDEMVY delivered another record quarter, and we're raising our full year outlook. That growth, along with our strong balance sheet, gives us the flexibility to keep expanding XDEMVY's reach while advancing each of our programs towards its next milestone. As Tarsus looks to 2027, we've never been in a stronger position to deliver for patients.

I will now turn the call back to Bobby for final remarks.

Bobak Azamian

Ten years ago, Tarsus was an idea built on a conviction. Patients with overlooked diseases deserve better. Today, we've brought an FDA-approved medicine to market and built an entirely new category of treatment. In just 3 years since launch, we've dispensed more than 1 million bottles of XDEMVY and generated over $1 billion in cumulative net product sales. And in the last few months, we've completed 2 acquisitions, expanding into the back of the eye. We've built a lot in a short time. And with every step, we've strengthened our ability to do it again. That's what gives me confidence in our ambition to build the next leader here and deliver more game-changing medicines to patients.

Operator, let's open the line for questions.

Operator

[Operator Instructions]

Bobak Azamian

This is Bobby, just in 3 years is truly extraordinary. Their commitment and consistency make me so proud and really give us greater capacity to do even more with XDEMVY and the rest of our pipeline. So thank you, the entire Tarsus team.

Operator

And our first question comes from Jason Gerberry with Bank of America.

質疑応答

Jason Gerberry

Maybe one for Jeff. I think past commentary suggested 43% to 45% gross to net be a good kind of operating assumption longer term to thinking about next year? Is that still appropriate? And then a pipeline question as we think about Stargardt I know the angle to differentiate here potentially would be around preservation of visual cycle. What do you think HCPs are looking at from a product labeling perspective around that consideration? Just thinking about potential differentiation angles here.

Jeffrey S. Farrow

Sure, Jason. Related to your gross to net question, we continue to believe 43% to 45% gross to net discount is what we'll see next quarter as well as into next year. You might recall that Q1 tends to be a little bit higher. But as the quarter progresses or the year progresses, we typically see that improve quarter-over-quarter, but we're still, I believe, that 43% to 45% gross to nets the appropriate discount for '27 as well.

Elizabeth Yeu

This is Liz Yeu. And with regards to your retinal question, as you know, it's a once-daily oral therapy, and that mechanism is designed to support that normal visual cycle and what our retina KOLs are telling us is this is a really unique and interesting mechanism that they are keenly looking forward to because as you know, withholding vitamin A from the retina can lead to unwanted potential side effects such as night vision and dark adaptation issues, the early programs for build retinal do demonstrate a very promising safety profile without any of the night blindness or at patient AEs. And we'll further test this with the Phase II North Star program and where our engagement opportunities have definitely demonstrated that the retina community is excited to have an oral therapy that would provide this.

Operator

Our next question comes from Andrea Newkirk with Goldman Sachs.

Andrea Tan

Congrats on the quarter. euro or Jeff, a question for you here on new patient volumes. Just curious if that's being driven more by patient request from the DTC campaigns or via organic slit-lamp screening. And Jeff, I guess, specifically, how should we expect DTC spend to trend in 2027? Do you expect that DTC will continue to remain elevated to support the long-term volume expansion? Or should we see some decrease going forward?

Neera Clase

Thanks, Andrea. In terms of your first part of your question, the 3 main drivers for volume growth are really DTC, where we actually are seeing 1 in 3 patients know about DB now through our DTC efforts and patients are actually asking for XDEMVY by name. The second part of that is execution, the sales force execution, which we've added approximately cows or key account leaders. And these folks are meaningfully contributing to expanding the conversation with doctors to really get them to think about the different patient types.

And then finally, the evidence that we talked about, we're seeing addressable TAM increases both at the table funnel at the bottom of the funnel. The evidence is really giving doctors confidence to look at more opportunities to potentially diagnose and treat and XDEMVY it comes to mind. I'll turn the other part of the conversation back to Jeff.

Jeffrey S. Farrow

Thanks, Neera. And Andre, to your question, that is something that we're looking at right now. Our assumptions for next year are still being looked at. But I think it's fair to say we're going to still spend a fair amount on DTC, probably in the same range that we spent this year in say, [indiscernible] range. The one thing that we've gotten better at is really seeing where we're seeing a better ROI and making investments in specific spots specific times. And in fact, our DTC investment in Q3 overall was less than what we did in Q2.

We bulked up in Q2 in anticipation of a little bit of a slowdown in the Q3 script dispensers and it definitely appeared to pay off. We had the John Cena campaign that we invested in Q2. And then you might recall we all did 2 disease education ads with double the cat and then the fan. And we think that was one of the reasons we saw a nice uptick in the latter part of August as well. So I think big picture, probably in the same range, but we might use similar to what we did this year as well between Q2 and Q3.

Operator

Our next question comes from Dennis Ding with Jefferies.

Unknown Analyst

So for me, when I think about all the positive signs you guys are seeing and compare that with consensus, which is 900 next year, but then $1.1 million in '28 and then [indiscernible] in '29, eventually $2 billion all the way out in 2035. Growth really need to slow down significantly, which means to me, there's either incremental net price erosion or perhaps XDEMVY is hitting a ceiling in terms of reaching new patients. So, number one, can you help us understand your assumptions on IRA and when you expect that to kick in? And then number two, what sort of proactive strategies do you have to reach out to the patients who haven't been treated yet, especially as you start bumping up into your addressable PAM.

Unknown Executive

Yes. Great question, Dennis. This is a new category. And unfortunately, there's not really a good analog for XDEMVY. It's something we struggled with to really help investors and analysts think about what this might look like. But we do anticipate -- every day, it's going to be one of those things where we're not "chronic" disease. So we basically started each quarter, start at 0 and have to drive new scripts. So that is part of the process in which we are categorizing and anticipating that growth to occur over time. Consensus might have us at 2035 for the $2 billion peak, but we have not given specific guidance yet. So I would take that with a great consult as well.

Neera Clase

I would add to that, Dennis, that what we're seeing is the physician experience has been remarkable. We are hearing overwhelmingly that they're getting more and more comfortable with thinking about XDEMVY expanding the patient types and really looking at ways that they're going to increase their utilization. Almost every doctor that we speak to, whether it's at conferences or during our fill and long is really looking for more patients to treat. And basically, we also did a survey where we found that 80% of ECP survey, they actually indicated that they would increase their overall prescribing in the coming year as they think about an expansion of the patient type for DB.

And then finally, what I would say is 98% of all of the eye care professionals that we're currently calling on really express satisfaction with XDEMVY, and that satisfaction actually has a spillover impact where they continue to find other additional patients and patient types.

Bobak Azamian

The only thing I would add, that's great, Neera, I think this strategy you've mapped out with ECP engagement, more and more patient engagement and importantly, evidence is really how we're going to be proactive. And we talked about those 25 million Americans with DB, and I'll pass to Liz to talk about some of her future strategies because I think evidence has been such a strong foundation for this great medicine.

Elizabeth Yeu

You make such a great point where there's 2 parts to this. There are at least 25 million Americans affected with [indiscernible] and in the eye care physician practice routinely, 58% or 1 or 2 patients are affected. As we enter year 4, there are 3 key opportunities. First, to better understand recurrence of the disease retreatment and long-term outcomes; second, further defining the clinical burden and the broader footprint of DB across different patient populations, as Neera mentioned; and third, generating evidence that would support earlier diagnosis in order to give ECPs that greater confidence and when and whom to treat.

And these efforts can help ECPs identify and more confidently make informed treatment decisions throughout the course of the disease.

Andrea Tan

Perfect. And if I can squeeze 1 more in, just on ALK 001. So thanks for the $150 million to $200 million guidance on the cost of approval. But, can you clarify what exactly was FDA's feedback on the Phase III? Because it seems like there's a little bit of ambiguity in terms of whether 1 or 2 Phase III studies will be needed. And also with on the table in terms of conducting an interim in 2028.

Seshadri Neervannan

Thank you for the question. This is Sesha Neervannan. So for ALK001, as you know, NorthStar is our Phase III study is largest prospective Phase III study in Star Gas disease powered very strongly for both primary and key secondary endpoints. And the FDA had fully endorse the study design and the endpoints and how we have positioned it. So there's a strong agreement with the FDA on the study itself. And we are positioning that as a primary pivotal trial. And of course, we have very strong data from the TS trial all 3 -- 4 -- these trials where we had looked at patient population, both early stage patients and late-stage patients both structural and functional visual LLVA responses and not to mention over 400 patients with over 7 years of tolerability data.

So a very strong data package to begin with. And as we continue the conversation with the FDA moving forward, the -- we have -- we keep the optionality of another Phase III trials open. We are still continuing to have those discussions and we'll update as soon as we have more information to share on that.

Operator

Our next question comes from Matthew Caufield with H.C. Wainright.

Matthew Caufield

With the really impressive growth for DB, are there important considerations for future prospective competition in the DB space, particularly considering an external topical iliad crane currently in Phase II and then just separately, can you remind us of the patent and IP runway for DMV and DB in terms of insulating the growth trajectory that we're seeing.

Jeffrey S. Farrow

This is Jeff. Fundamentally, we believe it's going to be a high bar to beat the success of XDEMVY, the efficacy and the safety profile and the thousands of patients that we've treated thus far has demonstrated that it's very safe and efficacious drug. The impact that we have seen some potential competition, it's interesting, they have taken approach of using a cream-based sort of elution. What we have chosen from -- based on our market research was to use an eye drop, that seemed to be preferential to the patient population, and it's something that they're used to versus twice-a-day application of HL or a cream.

And secondly, I think it's going to be one of those things that potentially more awareness could raise all boats here, too. So having patients have different choices can be beneficial for everybody in a situation like that. But again, I think it's going to be a high bar to actually beat the efficacy and profile of XDEMVY fundamentally.

Unknown Executive

Yes. And Matt, on your question on IP, we have runway through 2038, plus any Hatch-Waxman extensions.

Operator

Our next question comes from Jenna Davidner with Barclays.

Jenna Davidner

With respect to the guidance raised in the implied 4Q, coupled with the increased DTC investments -- can you just talk about the degree to which that guidance raise is driven by the DTC increase? And then on ocular rosacea, can you just remind us of the key endpoints and how we should think about the bar for success there given this is a new treatment category as well as the kind of forward to Phase III?

Bobak Azamian

Jenna, this is Bob. I just want to clarify your first question. I think you broke up a little bit. Can you just repeat it?

Jenna Davidner

With respect to the guidance range, the guidance raised in the implied 4Q, coupled with your increase in DTC investment, can you just help us understand the degree to which the DTC increase is driving the guidance range?

Neera Clase

Thank you, Jenna. The DTC, as you know, is one of the best campaigns probably out there, and we're really pleased to what we're seeing. While we're not providing specific numbers out there, what we can say is that it's very positive and growing at the higher end of the benchmarks that we see. And we're really, really pleased. We now have over a year of experience and we're getting a much clearer understanding of what drives the DTC performance. And certainly, those learnings are continuously going into how we think about things like guidance and how we deploy our investments.

We're really focusing on those channels and messages that generate the highest value engagement and so I know that you've heard in the prepared remarks that our full year spend is going up by $5 million, which brings our total spend up to $95 million. Again, another strong big driver for our growth in Q3 and as we move forward.

Unknown Executive

Yes. And regarding your question on ocular rosacea, as you know, this is the we're really #1 and we're really excited about this opportunity. And nobody has ever done an ocular rosacea study. So this is the first ever study in ocular rosacea with end points that have never been studied before. So, we are pursuing with the study. And the key endpoints there, as we had discussed with the FDA are the hallmark of the disease, which are really inflammation-driven and -- that includes erythema or redness around the eye as well as telangectasia, which is prominent self-blood vessels. So we are exploring these 2 endpoints plus additional exploratory end points. and we look forward to the data which is anticipated next year

Operator

Our next question comes from François Brisebois with LifeSci Capital.

François Brisebois

On the quarter. I was just wondering the Clearly, you mentioned the impact of John Cena and campaign and other DTC efforts here maybe in August. And I was just wondering, is that -- is that kind of a bullish impact you expect? Or is it still growing? Or did it hit and watch out? I'm just wondering in terms of your guidance here for the fourth quarter, just remind us maybe the cadence of that impact of those efforts and touching on the seasonality that you usually get in the fourth quarter?

Neera Clase

Yes. The DTC ROI is positive and growing and probably at the higher end of the benchmarks that we see. The way we think about it and the sequence of this, you could think about it in terms of branded, you have the John Cena social media campaign. You have the unbranded television advertising. You've heard us talk about Berry the cat and the fan ads that have been really instrumental in driving a lot of awareness and education. All of these things are working in concert. And what we've actually seen is a 75% increase in these high-value website actions.

And that actually signals to us more patients are probably likely to go see an ECP and then actually take advantage of some of the tools that we offer on the website. We are also seeing higher prescription conversion versus last year.

Jeffrey S. Farrow

This is Jeff. I'd just add to Neera's comments. So we are seeing sort of an accumulation of the impact of the DTC campaign. So the ROI is improving as you highlighted. -- earlier. And the other impact I would highlight too is KLs are also driving increased depth in prescribing -- and so the $5 million incremental is certainly adding to that aggregate amount, but we're noting that actually the increase we're doing is almost $28 million from the prior midpoint guidance. And so obviously, you're seeing some compounding effect of multiple factors here as well.

François Brisebois

Okay. No, that's very helpful. And then just a last one. I get a lot of questions around, and you mentioned kind of the retreatment. Is it that the colorants are coming back? Like do we have a better feel now how long it takes? Or is it certain that patients are prone for them to to come back? Or I guess what I'm trying to get to is I get a lot of people asking if people would just take it and maybe don't finish their bottle and then there's a little bit left and they use it again and so they don't get a -- like a refill I'm just wondering if that's something that happens despite maybe the bottle being expired or whatnot? Or anecdotally if you hear any of that?

Neera Clase

Thanks for the question. With regards to retreatment, we did perform a study that demonstrates that across physicians with extensive experience it appears that it's about 20% to 25% of patients require retreatment. Now that is based on clinician reported experience of the patients that they are seeing and that that is a set schedule for retreatment itself. With that being said, there are some comorbid conditions that may produce higher risk factors and tendencies, such as MGD or ocular rosacea and what's driving the retreatment is either, one, initiation of symptoms that the patients recognize or two, clinicians recognizing the sign of the Colorado.

Bobak Azamian

And this is Bobby. I'll just add. I love the -- all the questions about continued growth. I mean, we -- just to reiterate that we see this being multifactorial. We have lots of patients coming in from awareness. We have a very broad prescribing base and great activation with this new force the KLs calling on the top prescribers. And then we have the tailwind of retreatment. So we just see continued very strong growth for XDEMVY across the board because of multiple factors.

Operator

Our next question comes from Lachlan Hanbury-Brown with William Blair.

Lachlan Hanbury-Brown

Yes, guys, thanks for the questions. I think the strong growth in what's on only a seasonally slower quarter was pretty notable. So I was wondering if there were any any trends in sort of what was different? Like is that being driven by certain practices, geographies, channels, patient subtypes, anything that sort of explain how you were able to offset the seasonality there? And then maybe secondly, now that you have both iRenix and Alkeus in-house, is there anything else that you've learned like any new learnings about those programs that you maybe now that you've had more time with them that you maybe haven't picked up on jury diligence.

Unknown Executive

Can you just clarify the second question there, Lachlan.

Lachlan Hanbury-Brown

Just wondering if now that you've had now that you have ironic Altus in-house and have had some more time with those programs? Are there any sort of new learnings that you've had, you sort of haven't discovered during your initial diligence, but picked up on now that you've had them in your hands for a bit.

Neera Clase

In terms of the growth, what we have seen this quarter has been pretty substantial, right? And we're really pleased with what we're hearing. First and foremost, we're hearing more patients get activated and want to go in to see their doctors that's really driven a lot by the DTC efforts that we have deployed. Second, what we're also hearing is that doctors are really thinking about XDEMVY more front line. They're actually starting to include XDEMVY in terms of their treatment and retreatment protocols. And then thirdly, what we're hearing is also the evidence component.

We released 11 abstracts at the most recent medical conference, and they were very well received, and this is our opportunity to continue to educate and make awareness and drive that. When you couple all of these efforts and initiatives together, along with the execution of the sales team, the cows that we've talked about, you really see this opportunity and growth that's really accelerating here in the back half of the year. We're really pleased with what we're seeing.

Unknown Executive

And Lachlan, on your acquisition question. It's a great question. I think on the iRenix transaction, we're finding even more excitement about this as a potential new antiseptic. I think people see this as potentially a new standard of care. So the more we dig into that from a market research perspective, the more excited we get about it. And then of killers on Alkeus, it's a much bigger transaction. This is the first sort of big integration that we've done.

And we put a lot of effort time into making sure that they feel part of Tarsus and that we continue to execute on that. So we set up a really strong cross-functional team of next level leadership that is really taking the lead on making sure that the clinical studies move forward timely, that there's good communications between both entities and that we maintain the exciting culture that we've got here at Tarsus and Alkeus. And so I think those are some of the new things that really had sort of built over time there.

Operator

Our next question comes from Mazahir Alimohamed with Oppenheimer.

Mazahir Alimohamed

Congratulations on the quarter and -- so I think for us, firstly, kind of thinking about iRenix 101 and following back on what Jeff just said, I think kind of top of mind for us is thinking through the reimbursement strategy. And kind of how exactly you're thinking about going forward with that? Is that something where you anticipate like a separate payment or a J code? Or do you anticipate to be bundled into the procedure and kind of secondly, on that, given the lean kind of cost to approval, is the plan a single Phase III on a 505(b)(2) pathway?

Neera Clase

Thank you. In terms of the IRX 101, it is going to be a separate payment. We're looking for J code. They'll likely also be what we call a C code at point of launch. So as you know, in this -- with this particular product, this is a buy-and-bill product done in the offices. So the provider economics really matter and we're really looking forward to leveraging our market access expertise as we potentially bringing this drug to market.

Seshadri Neervannan

Yes. And regarding your question on the regulatory pathway. This is a new chemical entity. And the label we're pursuing is an ocular antiseptic label. And for that label, the efficacy studies come from in vitro microbiological studies across multiple different organisms as defined by the coupled with a clinical safety trial that will constitute the full package for India filing.

Operator

Our next question comes from Eddie Hickman with Guggenheim Securities.

Unknown Analyst

And congrats on the great quarter. sorry to repeat if this has been asked before. But assuming positive data for TPO 4, how quickly could you move into a Phase III? And since you gave cost to approval for iRenix 101 to retinal -- like how should we think about the overall development cost and commercial footprint for the oculars, especially given the overlap with the XDEMVY call point. Appreciate it.

Unknown Executive

So regarding your question on ocular rosacea, as I mentioned earlier, this is the first ever study. So we are looking at multiple different aspects of the study, and we'll have to look at the data next year and proceed assuming the data is positive, we will move into a Phase III study either later next year or the following year. That's generally our plan. But first things first, we have to complete our ongoing study and read out the data.

Neera Clase

Regarding the commercial footprint, we're pretty excited about the ocular rosacea indication should it be approved. I think in terms of that, what we can think about is with XDEMVY, we created a category. And this is very similar to that and that it is something that is new and something that doctors tell us all the time that they see a lot of in their practice. So we're excited about the opportunity ahead and can leverage a lot of synergies and call points from what we currently see with Demodex learns treatment rate. Go ahead, sorry, sorry.

Jeffrey S. Farrow

Sorry, it's Jeff. Just following up on that. So yes, there's a Neera highlighted, there's a lot of synergies with our footprint there. So we wouldn't expect to be expanding in a large fashion as it relates to the commercial footprint. And then sort of pivoting off of what Sasha said on the Phase III study, it's probably a little early to give an estimate on the cost for that yet until we have a good sense of what the design is following feedback from the agency.

Unknown Analyst

Got it. And on that XDEMVY retreatment rate that you noticed, correct me if I'm wrong, but that sort of approaching or at where the steady state that you guided for. Are you changing that guidance or what you expect that long-term retreatment or refill rate to be?

Jeffrey S. Farrow

Yes. We basically are saying it's in the low 20s. And it's evolved over time, as you know, we sort of estimated it to sort of land there. And it's gotten from the time of launch, we've seen it go from sort of low single digits to high double teens and now we're in the low 20s. We'll have to monitor that over time to see where -- if it needs to be adjusted again. But I would say it's been -- we've adjusted it to be low 20s from, say, 20%.

Operator

Our next question comes from Graig Suvannavejh with Mizuho.

Graig Suvannavejh

Congrats on the quarter. And let me add my congrats to Neera on becoming officially Chief Commercial Officer. Neera, maybe a question for you just from a high level. Obviously, you've been in the organization for a while, but now as you're officially CCO. Any comments you can make on tweaks that perhaps you are thinking about implementing or have implemented. Obviously, it's a well-oiled machine as is, but just any thoughts as you're now leading the organization?

And then second question, if I could just revisit the Alkis product that you were now developing, could you just remind us of the IP position of the product or is this a composition of matter patent? Is there a method of use patent or any other formulation patents? Any dates whether that includes or doesn't include PPA or PTE would be helpful there.

Neera Clase

Greg, thank you so much for the congratulations. That certainly means a lot. And I'm really grateful and honored for this opportunity. I can tell you that the first thing I think about when I think about the opportunity is XDEMVY and how great the drug is in and of itself. And then secondly, the team that we have behind it and the expertise that we've created over time, including the competitive differentials within the team, everything from market access to marketing to our sales force execution. I think the playbook is working.

And so we want to continue to work on that playbook and execute it flawlessly as we move forward. There's always going to be things that we look at in terms of how can we improve and how can we continue to accelerate the trajectory. We have some big goals to achieve, obviously, guidance for this year. And then as we move forward, eventually getting to peak sales of $2 billion plus, so we're excited about what's ahead. And really, I can tell you that you can expect to see a lot of what we're doing today with little potential tweaks as we move forward.

Jeffrey S. Farrow

And Greg, with regard to your question on IP on the Alkeus product, we're guiding right now to orphan exclusivity, composition of matter has expired. So think about 7, 7.5 years from approval. That said, our General Counsel is a patent attorney by training and he set us up for success with the XDEMVY patents here. And so he's looking at other opportunities potentially method of use coming out of the data that we are going to be collecting in the Phase III study as well. So we're looking to potentially get some upside potential there.

Operator

Thank you. And this concludes the conference. Thank you for your participation.